AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER— 510(k) K081841

Name: FDA 510(k) clearance K081841
Creator: U.S. Food and Drug Administration
Published: 2008-07-16

Substantially Equivalent

Amplivox, Ltd.

FDA 510(k) clearance K081841 for AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER, Substantially Equivalent on 2008-07-16. Applicant: Amplivox, Ltd.. Device class: 2.

Clearance details

Applicant: Amplivox, Ltd.
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2008-06-30
Decision date: 2008-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.